BVX-0320 / BioVaxys - LARVOL DELTA

"$BVAXF BioVaxys Bioproduction Partner WuXi Biologics Completes Synthesis Of Recombinant SARS-CoV-2 s-proteins for BVX-0320 and CoviDTH Programs https://t.co/HidHnMGTak" (@otcdynamics)

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

BioVaxys Expands Intellectual Property Portfolio (Canada Newswire) - "BioVaxys Technology Corp....announced today that it is expanding its intellectual property portfolio with the filing of an international patent application through the Patent Cooperation Treaty ('PCT') for its haptenized viral antigen vaccine platform, including new claims for a multivalent version of BVX-0320...The planned multivalent version of the BioVaxys vaccine is a combination of the haptenized spike protein subunits from each newly emerging, highly transmissible, SARS-CoV-2 variants..."

Patent • Infectious Disease • Novel Coronavirus Disease

BioVaxys Enters Major Bioproduction Agreement With Wuxi Biologics (Hong Kong) Ltd. To Synthesize Proteins For Its SARS-CoV-2 Vaccine And COVID-T Immunodiagnostic Programs (PRNewswire) - "BioVaxys Technology Corp....has entered into a major bioproduction agreement with WuXi Biologics Limited...to produce SARS-CoV-2 s-proteins required by BioVaxys for BVX-0320...BioVaxys will be able to secure the level of purity, consistency and protein characterization required by the U.S Food and Drug Administration...facilitating the future production of GMP-grade s-protein for human trials and future commercial-scale production. Synthesized GMP-grade s-protein is used...in BVX-0320...which is also being prepared for a clinical study this year. BioVaxys will submit its pre-IND meeting request to the FDA for Covid-T early next month."

Commercial • Infectious Disease • Novel Coronavirus Disease

BioVaxys Announces Initiation of Cancer Vaccine EU Clinical Program, Completion of BVX-0320 Preclinical Program (PRNewswire) - "BioVaxys is pleased to announce that it has commenced the clinical development program for BVX-0918A, its haptenized tumor antigen vaccine for ovarian cancer. The Company plans to seek a compassionate use approval in the European Union ('EU') for Stage III & Stage IV ovarian cancer, followed by submitting an IND in the US. BioVaxys is in discussions with its designated Contract Manufacturing Organization ('CMO') and anticipates the execution of a manufacturing contract in 1Q21. The Company plans to submit its Clinical Trial Application ('CTA') for BVX-0918A with the European Medicines Agency ('EMEA') later this year."

Commercial • European regulatory • Gynecologic Cancers • Oncology • Ovarian Cancer